Intraocular Pressure
Conditions
Brief summary
Clinical validation of iCare ST500 tonometer per ANSI Z80.10:2014 standard
Interventions
DEVICEiCare ST500
Measurement of Intraocular Pressure (IOP)
DEVICEGAT
Measurement of Intraocular Pressure (IOP)
DEVICEiCare IC200
Measurement of Intraocular Pressure (IOP)
Sponsors
Icare Finland Oy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Investigator cannot see the measurement results.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients at least 18 years old
Exclusion criteria
1. Subjects with only one functional eye 2. Subjects having poor or eccentric fixation in the study eye(s) 3. High corneal astigmatism \>3D in the study eye(s) 4. Central corneal scarring 5. History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s) 6. Microphthalmos 7. Buphthalmos 8. Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally 9. Dry eyes (clinically significant) 10. Lid squeezers - blepharospasm 11. Nystagmus 12. Keratoconus 13. Any other corneal or conjunctival pathology or infection relevant to this study 14. Central corneal thickness greater than 600 μm or less than 500 μm in the study eye(s) 15. Cataract Extraction within last 2 months in the study eye(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers | Through study completion, an average of 4 months | Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups. |
Countries
Canada
Outcome results
None listed